Michael Causey, Editor & Publisher, eDataIntegrityReport.com
UPDATE! (July 2010): FDA: eMDR Guidance Probably Won’t Happen This Summer.
Lucy of “Peanuts” fame liked to ask Charlie Brown to come kick that football, only to yank it away at the last minute. That’s kind of how I feel waiting for the FDA to release its final eMDR rule.
Officially, the FDA isn’t saying much publicly. But well-placed sources within the agency have told us in the past that it was “coming soon,” even going so far as to say many months ago that it would be released February 2010.
Guess what? The agency missed that deadline, too. We’re hearing it’s been delayed for a slew of reasons; and few, if any, have to do with the content in the rule itself. Indeed, the agency has been surprised how little comment the eMDR rule proposal received. It’s no longer very controversial, and industry realizes that it is going to happen.
And I feel like Charlie Brown again, but here goes: FDA inside sources told us yesterday that it will be released next month. If that new deadline holds, it is also likely to be mandated within a year of its release, so mark June or July 2011 on your calendar for that.
Indeed, CDRH even placed eMDR at #4 on its top priorities list for 2010.
But the FDA has had its hands full and not enough hands to juggle it all. So, chalk the eMDR delay up to internal FDA issues, e.g. lack of staff, other “higher priorities” knocking the eMDR rule off a person’s desk while they put out another fire, etc.
The agency is committed to eMDR, and industry should be too. Once it is up and humming, it will improve productivity, reduce errors, and cut some compliance costs, too.
Watch this space for the latest developments.
I am not surprised that the FDA’s release of its file rule for eMDRs has taken so long. Now that it has been kicked around a long time by the Agency, I am glad the file rule on eMDRs has not fallen into the Black Hole of Part 11 and Third Party Inspections.